Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-02 @ 5:48 AM
Study NCT ID:
NCT07074067
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robotically Assisted or Not): ENOLA TRIAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time taken to perform surgery', 'timeFrame': 'Perioperative', 'description': 'Surgical time will be defined, in the case of the laparoscopic/robotic route, as the time elapsed from the insertion of the first trocar to the removal of the last one, and in the case of the v-NOTES route, as the time elapsed from the beginning of the vaginal surgery to the end of the surgery. The previous time of positioning of the patient, anesthesia, asepsis and sizing of the surgical field will not be taken into account'}], 'secondaryOutcomes': [{'measure': 'AGE', 'timeFrame': 'Day 1', 'description': 'Number of years'}, {'measure': 'Body Mass Index', 'timeFrame': 'Day 1', 'description': 'numerical variable measured in "Kg/m2'}, {'measure': 'times spent in surgical techniques', 'timeFrame': '1 day post surgery', 'description': 'number of minutes the surgery lasts'}, {'measure': 'Measurement of post-surgical pain', 'timeFrame': '6 and 24 hours after the intervention', 'description': 'using the Visual Analog Scale (VAS) in the immediate postoperative period It consists of a 10-centimeter straight line, where one end represents the absence of pain (0) and the other, the worst pain imaginable (10).'}, {'measure': 'Study of overall patient satisfaction upon hospital discharge', 'timeFrame': 'Trough study completion, an average of a1 year', 'description': 'Study of overall patient satisfaction upon hospital discharge: "SERVQHOS (quality of hospital services) a questionnaire to assess the perceived quality of hospital care through 20 items across 5 dimensions, each item is rated using a Likert-type(1-7) scale allowing free subjective evaluation.'}, {'measure': 'Study of patient quality of life before and one month after surgery', 'timeFrame': '0, 30 days post surgery', 'description': 'SF12 V2 Quality of Life Questionnaire"SF-12v2 is a shortened form (12 items) of the SF-36v2 Health Survey. (minimum 20 points maximum 60 points)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The v-NOTES surgical approach may provide important advantages over the already established effective technique (laparoscopy) for safely and successfully removing the uterus and adnexa in patients with low-grade endometrioid adenocarcinoma FIGO IA and atypical endometrial hyperplasia, such as a better aesthetic outcome, a shorter hospital stays, and a decrease in pain and postoperative complications. without increasing surgical time and with equal safety for the patient.', 'detailedDescription': "A prospective, open-label, longitudinal, randomized, longitudinal, blind-blind third-party (observer-blind) clinical trial will be conducted. Patients with a diagnosis of endometrioid adenocarcinoma IA G1-G2 and atypical endometrial hyperplasia will be recruited in the Gynecology Oncology consultations of the HCUVA. Patients who meet all the inclusion criteria and none of the exclusion criteria from the trial will be informed about the study, and if they agree to participate, they will sign the informed consent. The data will be included in the Hospital's computer system (Selene), and will be compiled in a database that will be accessible only by the physicians included in the study. Subsequently, this database will be analysed by a statistician from outside the HCUVA's Gynaecology Service. After surgery, patients will be monitored after surgery, first on the hospitalization floor prior to discharge, and later in face-to-face consultations as well as by telephone."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with endometrial cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of majority (\\> 18 years)\n* Willingness to participate in the study and signing of informed consent\n* Histological diagnosis, by endometrial biopsy (either using a Cornier cannula or directed by diagnostic hysteroscopy) of atypical endometrial hyperplasia or low-grade endometrioid adenocarcinoma (G1-G2), with an initial stage (IA) at preoperative evaluation\n\nExclusion Criteria:\n\nPregnant Women\n\n* Nullicottitis\n* Severe uterine prolapse (grade IV)\n* Large myomatous uterus (greater than 18 weeks of gestation)\n* Severe comorbidities that contraindicate surgery, such as sepsis, severe renal failure, severe cardiopulmonary disease, or severe coagulopathies 33\n* Presence of previous illnesses or treatments that may have caused severe pelvic adhesions that obliterate the Douglas pouch and prevent vaginal entry, such as deep pelvic endometriosis, severe pelvic inflammatory disease, inflammatory bowel disease (ulcerative colitis, diverticulitis, Crohn's disease), or a history of pelvic radiotherapy, among others\n* Concomitant presence of adnexal masses or formations of considerable size that are expected to substantially lengthen the uterus Surgical time due to the difficulty of extraction\n* Contraindication to general anesthesia\n* Active pelvic or lower urinary tract infection\n* Clinical suspicion of advanced stage of the neoplasia\n* Any histological type of endometrial cancer other than those described previously.\n* High histological grade (G3)\n* Current abnormality in cervical cytology (CVC) requiring more aggressive surgical intervention\n* Revocation of informed consent"}, 'identificationModule': {'nctId': 'NCT07074067', 'acronym': 'ENOLA', 'briefTitle': 'V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robotically Assisted or Not): ENOLA TRIAL', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia'}, 'officialTitle': 'V-Notes Hysterectomy in Patients With Endometrial cáncer Compared With Laparoscopic Surgery (Robotically Assisted or Not): ENOLA TRIAL', 'orgStudyIdInfo': {'id': '2022-4-5-HCUVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic surgery', 'description': 'within the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.', 'interventionNames': ['Procedure: Laparoscopic surgery']}, {'type': 'EXPERIMENTAL', 'label': 'surgery via v-NOTES', 'description': 'surgery via v-NOTES', 'interventionNames': ['Procedure: surgery via v-NOTES']}], 'interventions': [{'name': 'Laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'the laparoscopic (LPC) arm, 21 patients will be assigned to conventional LPC and another 21 to robotic surgery, consecutively.', 'armGroupLabels': ['Laparoscopic surgery']}, {'name': 'surgery via v-NOTES', 'type': 'PROCEDURE', 'description': 'surgery via v-NOTES', 'armGroupLabels': ['surgery via v-NOTES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'HCUVA', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Rafael Guijarro Campillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCUVA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}